FDA.reportPublic FDA data

La Flecha Japonesa

Product NDC
53145-047
11-digit product format
531450047
Labeler code
53145
Product ID
53145-047_3a89cc64-eb78-0ae0-e063-6394a90a706c
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
Menper Distributors, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-21
Substance
METHYL SALICYLATE
Active strength
105 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct53145-047EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53145-04753145-047-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
La Flecha Japonesa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE105 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2719838Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
08819ad0-97c2-49bd-b923-535b94a27167Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-07-28La Flecha Japonesa
2022-02-18La Flecha Japonesa
2022-01-28La Flecha Japonesa
2020-02-27La Flecha Japonesa
2020-01-31La Flecha Japonesa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-047-01La Flecha Japonesa1 in 1 CARTONOIL15
53145-047-01La Flecha Japonesa15 mL in 1 BOTTLE, GLASSOIL155

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YLA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZLA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
CAJUPUT OILINACTIVE INGREDIENTJ3TO6BUQ37LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
CLOVE OILINACTIVE INGREDIENT578389D6D0LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
JUNIPER BERRY OILINACTIVE INGREDIENTSZH16H44UYLA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ALA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPLA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHLA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH Lidocaine Plus MentholLIDOCAINE, MENTHOLARMY AND AIR FORCE EXCHANGE SERVICE60f72061-d264-424e-b396-5a609076d3522026-08-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF5980c527-6bcb-a846-e063-6294a90a07882026-08-20WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergen5fb5e5ce-b268-4444-8b63-ea7ea6abf2692026-08-20WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsExact identifier
application number: M017
Eagle Brand Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0822bcde-a8ad-be95-e063-6294a90ad2082026-08-19WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONEHyVee Inc1ab6bbb8-2b91-4c53-9168-b1e85ac296e92026-08-19WarningsExact identifier
application number: M017
hydrocortisone 1HYDROCORTISONEKroger Companyf05edff2-2dc5-427c-b52c-518e0aaef4e02026-08-19WarningsExact identifier
application number: M017
MedPrideHYDROCORTISONEShield Line LLC2f15d3b3-d1e6-4742-9eac-f956c0ffbba42026-08-18WarningsExact identifier
application number: M017
Pain Relieving Cream AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEGarcoa, Inc.2f736307-5cd4-4a76-9044-4aeecba096cc2026-08-18WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll onPAIN RELIEF ROLL ONNeilMed Pharmaceuticals Inc58ff9d2d-99e6-8f98-e063-6394a90a8de72026-08-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1/2%Sun Pharmaceutical Industries, Inc.59337940-c9be-58af-e063-6394a90abe132026-08-16WarningsExact identifier
application number: M017
SIERQ NumbingMENTHOLPutian Licheng District Zhijiancheng Trading Co., Ltd.5936c070-d8e4-56e8-e063-6294a90a56002026-08-16WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5911d9b0-1acb-3546-e063-6294a90adb3a2026-08-15WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology59072f05-eefa-d823-e063-6394a90a0e1a2026-08-14WarningsExact identifier
application number: M017
JJ Care First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCINantong Health & Beyond Hygienic Products Inc.c41621fb-c549-4394-a4cb-cb81ef8c98df2026-08-13WarningsExact identifier
application number: M017
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
application number: M017
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC5384e80f-c242-76a1-e063-6294a90aba0b2026-08-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2719838methyl salicylate 10.5 % Topical OilPSN08819ad0-97c2-49bd-b923-535b94a271675
2719838methyl salicylate 105 MG/ML Topical OilSCD08819ad0-97c2-49bd-b923-535b94a271675
2719838methyl salicylate 10.5 % Topical OilSY08819ad0-97c2-49bd-b923-535b94a271675

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53145-047-01531450047011 BOTTLE, GLASS in 1 CARTON (53145-047-01) / 15 mL in 1 BOTTLE, GLASS2012-02-210000-00-00NoNoCurrent